FDA Product Code LDF: Electrode, Pacemaker, Temporary
Temporary pacemakers provide immediate cardiac pacing during hemodynamic emergencies. FDA product code LDF covers temporary pacemaker electrodes used for short-term cardiac stimulation.
These catheters are placed transvenously or epicardially to deliver electrical impulses to the myocardium for temporary rate support during symptomatic bradycardia, post-cardiac surgery, and as a bridge to permanent pacemaker implantation.
LDF devices are Class II medical devices, regulated under 21 CFR 870.3680 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Medtronic Vascular, C.R. Bard, Inc. and Electro-Catheter Corp..
129
Total
129
Cleared
134d
Avg days
1978
Since
129 devices
Cleared
Oct 20, 1983
MULTIPOLAR TEMPORARY CARDIAC
Oscor, Inc.
Cardiovascular
139d
Cleared
Oct 19, 1983
EPCOR MULTIELECTRODE TEMP. PERVENOUS
Cordis Corp.
Cardiovascular
79d
Cleared
Oct 19, 1983
ELECATH PACEWEDGE DUAL PRESS. BIPOLAR
Electro-Catheter Corp.
Cardiovascular
58d
Cleared
Apr 18, 1983
TEMP. PACING LEAD, BIPOLAR #TH60, 90/110
Oscor, Inc.
Cardiovascular
38d
Cleared
Feb 18, 1983
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE
C.R. Bard, Inc.
Cardiovascular
38d
Cleared
Mar 15, 1982
TRANSLUMINAL BIPOLAR PACING PROBE
American Edwards Laboratories
Cardiovascular
89d
Cleared
Dec 10, 1981
ETHICON* TEMP. CARDIAC PACING WIRE
Ethicon, Inc.
Cardiovascular
34d
Cleared
Nov 16, 1981
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD
Medtronic Vascular
Cardiovascular
49d
Cleared
Oct 29, 1981
TEMPORARY PERVENOUS J-ATRIAL LEAD
Cordis Corp.
Cardiovascular
24d
Cleared
Sep 21, 1981
USCI TRANSTHORACIC TEMP. PACING ELECTROD
C.R. Bard, Inc.
Cardiovascular
35d
Cleared
Jul 20, 1981
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880
Medtronic Vascular
Cardiovascular
69d
Cleared
Apr 08, 1981
ATRIAL-VENTRICULAR PACING ELECTRODE KIT
Stanco Medical, Inc.
Cardiovascular
29d
Cleared
Apr 08, 1981
UNIVERSAL PACING ELECTRODE KIT
Stanco Medical, Inc.
Cardiovascular
29d
Cleared
Apr 08, 1981
TEMPTRON #'S 6804/6805
Medtronic Vascular
Cardiovascular
28d
Cleared
Mar 04, 1981
ELECATH DUAL MODE TRANSTHORACIC PACING
Electro-Catheter Corp.
Cardiovascular
27d
Cleared
Feb 05, 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
Cordis Corp.
Cardiovascular
29d
Cleared
Jan 16, 1981
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
American Edwards Laboratories
Cardiovascular
45d
Cleared
Oct 23, 1980
TRANSVENOUS PACEMAKER ELECTRODE KIT
Stanco Medical, Inc.
Cardiovascular
37d
Cleared
Apr 16, 1980
USCI BIPOLAR BALLON PACING ELECTRODE
C.R. Bard, Inc.
Cardiovascular
65d
Cleared
Jul 12, 1979
SWAN-GANZ FLOW-DIRECTED CATHETER
Edwards Lifesciences, LLC
Cardiovascular
17d
Cleared
Dec 04, 1978
TEMPORARY CARDIAC PACING WIRE
Ethicon, Inc.
Cardiovascular
172d